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Indian Journal of Medical Microbiology 2016Diagnosis of gonorrhoea is an ongoing challenge. The organism is fastidious requiring meticulous collection and transport for successful cultivation. Asymptomatic... (Review)
Review
Diagnosis of gonorrhoea is an ongoing challenge. The organism is fastidious requiring meticulous collection and transport for successful cultivation. Asymptomatic infections are common which go undetected by conventional methods thereby leading to continued transmission and the risk of complications. The nucleic acid amplification tests, now increasingly used in developed countries, offer improved sensitivity compared to bacterial culture. However, these continue to suffer sequence related problems leading to false positive and false negative results. Further, these cannot be used for generation of data on antibiotic susceptibility because genetic markers of antibiotic resistance to recommended therapies have not been fully characterised. They are unaffordable in a setting like ours where reliance is placed on syndromic approach for sexually transmitted infection (STI) management. The use of syndromic approach has resulted in a considerable decline in the number of Neisseria gonorrhoeae isolates that have been cultured for diagnostic purposes. Many laboratories formerly doing so are no longer performing culture for gonococci, and the basic skills have been lost. There is a need to not only revive this skill but also adopt newer technologies that can aid in accurate diagnosis in a cost-effective manner. There is room for innovation that can facilitate the development of a point-of-care test for this bacterial STI.
Topics: Diagnostic Services; Diagnostic Tests, Routine; Gonorrhea; Humans; Neisseria gonorrhoeae
PubMed: 27080763
DOI: 10.4103/0255-0857.180278 -
Nutrients Feb 2020At present, specialized companies offering genetic testing services without the involvement of clinicians are growing; this development is a direct consequence of the... (Review)
Review
At present, specialized companies offering genetic testing services without the involvement of clinicians are growing; this development is a direct consequence of the significant decrease in genotyping and sequencing costs. Online companies offer predictions about the risk of developing complex diseases during one's life course, and they offer suggestions for personal lifestyle. Several companies have been created that provide nutrigenetics services; these companies suggest dietary indications-a central issue in the prevention and etiopathogenesis of specific diseases-based on one's personal genetic background. Dietary patterns are defined on the basis of a limited set of genetic markers. In this article, we analyze the online nutrigenetics services offered by 45 companies worldwide, to obtain an overall picture of the costs, the types of nutritional traits considered and the level of scientific precision of the services proposed. Our analysis clearly highlights the need for specific guidelines, in order to ensure a set of minimum quality standards for the nutrigenetics services offered to the customer.
Topics: Direct-To-Consumer Screening and Testing; Genetic Testing; Guidelines as Topic; Humans; Nutrigenomics
PubMed: 32098227
DOI: 10.3390/nu12020566 -
The Journal of Molecular Diagnostics :... Sep 2019Developments in diagnostics reform legislation in the United States are occurring at a rapid pace. The framework for future regulatory oversight of clinical laboratory... (Review)
Review
Developments in diagnostics reform legislation in the United States are occurring at a rapid pace. The framework for future regulatory oversight of clinical laboratory testing is currently under intensive debate among stakeholders that represent patients, practitioners, laboratories, diagnostic manufacturers, and regulators. The importance of clinical laboratory test standardization is a key component of any plan for regulatory reform. A laboratory-developed test is performed in a specific laboratory setting, often led by clinical laboratory professionals who possess specific expertise for developing and running the test to fill a clinical need. A test commercially marketed as an in vitro diagnostic kit is designed to operate across a spectrum of laboratory settings in laboratories with a range of expertise. Both types of tests are stringently regulated, laboratory-developed tests by the Clinical Laboratory Improvement Amendments and in vitro diagnostic kits by the US Food and Drug Administration. Interlaboratory comparisons of laboratory-developed tests have been published, demonstrating highly reproducible results. Comparisons of laboratory-developed tests with in vitro diagnostic kits have also found high concordance. Several important clinical laboratory test standardization projects are currently under way. The US Food and Drug Administration has acknowledged the need for such standardization. In its most recent draft guidance, the agency requested input from the scientific community as to actions that can be taken to facilitate standardization.
Topics: Clinical Laboratory Services; Clinical Laboratory Techniques; Humans; Quality Assurance, Health Care; United States; United States Food and Drug Administration
PubMed: 31075512
DOI: 10.1016/j.jmoldx.2019.04.002 -
AMA Journal of Ethics Aug 2016Since the 1990s, the fields of anatomic and clinical pathology have made strong commitments to improving patient safety, including the creation of formal and informal... (Review)
Review
Since the 1990s, the fields of anatomic and clinical pathology have made strong commitments to improving patient safety, including the creation of formal and informal guidelines for assessing and reporting quality lapses. Unfortunately, some medical errors are inevitable. Patient safety experts advocate full and complete disclosure of all serious medical errors in an effort to preserve the patient-physician relationship and minimize the risk of harm to patients. While evidence suggests that most pathologists disclose serious medical errors, many do not disclose such errors to patients. A literature review of articles published on diagnostic error disclosure in pathology and laboratory medicine suggests that there are in fact persistent barriers to the disclosure of diagnostic errors that are specific to pathology. A number of these barriers are considered here, followed by recommendations for improving patient safety in pathology.
Topics: Clinical Laboratory Services; Communication; Diagnostic Errors; Ethics, Medical; Humans; Laboratories; Pathology, Clinical; Patient Safety; Physician-Patient Relations; Truth Disclosure
PubMed: 27550565
DOI: 10.1001/journalofethics.2016.18.8.nlit1-1608 -
Consolidation of Clinical Microbiology Laboratories and Introduction of Transformative Technologies.Clinical Microbiology Reviews Mar 2020Clinical microbiology is experiencing revolutionary advances in the deployment of molecular, genome sequencing-based, and mass spectrometry-driven detection,... (Review)
Review
Clinical microbiology is experiencing revolutionary advances in the deployment of molecular, genome sequencing-based, and mass spectrometry-driven detection, identification, and characterization assays. Laboratory automation and the linkage of information systems for big(ger) data management, including artificial intelligence (AI) approaches, also are being introduced. The initial optimism associated with these developments has now entered a more reality-driven phase of reflection on the significant challenges, complexities, and health care benefits posed by these innovations. With this in mind, the ongoing process of clinical laboratory consolidation, covering large geographical regions, represents an opportunity for the efficient and cost-effective introduction of new laboratory technologies and improvements in translational research and development. This will further define and generate the mandatory infrastructure used in validation and implementation of newer high-throughput diagnostic approaches. Effective, structured access to large numbers of well-documented biobanked biological materials from networked laboratories will release countless opportunities for clinical and scientific infectious disease research and will generate positive health care impacts. We describe why consolidation of clinical microbiology laboratories will generate quality benefits for many, if not most, aspects of the services separate institutions already provided individually. We also define the important role of innovative and large-scale diagnostic platforms. Such platforms lend themselves particularly well to computational (AI)-driven genomics and bioinformatics applications. These and other diagnostic innovations will allow for better infectious disease detection, surveillance, and prevention with novel translational research and optimized (diagnostic) product and service development opportunities as key results.
Topics: Animals; Artificial Intelligence; Automation; Clinical Laboratory Services; Clinical Laboratory Techniques; Communicable Diseases; Humans
PubMed: 32102900
DOI: 10.1128/CMR.00057-19 -
Journal of Vascular Surgery Feb 2020Little is known about the public's knowledge of abdominal aortic aneurysms (AAA). Although preventive screening is available, millions of Americans remain unaware of...
OBJECTIVE
Little is known about the public's knowledge of abdominal aortic aneurysms (AAA). Although preventive screening is available, millions of Americans remain unaware of their risk. Improved health literacy has been associated with increased screening and improvement in health outcomes. This study assessed the level of AAA literacy among respondents who participated in a free AAA screening event.
METHODS
Thirteen key words used by vascular surgeons to describe the risk, diagnosis, and treatment options for AAA were extracted from the screening tool used by the nation's largest provider of free AAA diagnostic services, AAAneurysm Outreach. The National Institutes of Health recommends readability of patient education materials to be at the sixth-grade level, but a readability analysis of these words placed them at a grade level of 14.6. A self-administrated questionnaire was developed that allowed respondents to compare each of the extracted words with a definitionally correct or incorrect word that reflected a sixth-grade readability score. These scores were then compared with the available demographics.
RESULTS
There were 570 completed questionnaires. Of the participants, 57.6% were female, 61.4% were 60 and above, and 32.6% were veterans. The average number of correct answers was 9.31 out of 13 (72% correct). Only 4.7% answered all questions correctly, with 29.1% missing five or more answers. The most frequently missed words were asymptomatic, screening, and cholesterol (56.5%, 44%, and 41.4% incorrect, respectively). The most frequently known terms were abdominal, diagnosis, and genetic (96%, 95.3%, and 91.9% correct, respectively). The remaining words fell between these extremes. Those aged 60 and above scored significantly lower than younger respondents (P < .0001). A post hoc power analysis indicated that the power to detect the obtained effects of age at the .05 level was greater than 0.95. Gender and veteran status did not produce any significant differences.
CONCLUSIONS
These data suggest an important communication gap between the words used by clinicians to describe the risks, diagnostic results, and treatment options of AAA and the targeted at-risk population, especially those 60 years and older.
Topics: Aortic Aneurysm, Abdominal; Comprehension; Female; Health Literacy; Humans; Male; Mass Screening; Middle Aged; Retrospective Studies; Self Report; Terminology as Topic
PubMed: 31204214
DOI: 10.1016/j.jvs.2019.03.063 -
Polskie Archiwum Medycyny Wewnetrznej 2016Despite being ubiquitous in primary care, there is no accepted consensus on the definition and main components of health checks. They range from periodic health... (Review)
Review
Despite being ubiquitous in primary care, there is no accepted consensus on the definition and main components of health checks. They range from periodic health evaluations with a general physician, through the screening and diagnostic tests derived from these visits, to broader screening programs. Health checks may promote a fluid patient-provider relationship, improve the delivery of some preventive measures, and reduce the patient's anxiety. However, they can also expose patients to overdiagnosis and unnecessary interventions. Research on the benefits, harms, and cost-effectiveness of health checks is limited. As a consequence, health checks and screening programs are implemented in several countries and supported by national scientific societies based chiefly on their potential benefits on surrogate outcomes. There is also substantial variability regarding the target population (eg, initial age), tests, or intervals. We call for a rigorous assessment of the net effect of all health checks, taking into consideration common biases (eg, sticky-diagnosis and slippery-linkage biases), patient-important outcomes, potential adverse events, cost-effectiveness, as well as equity and feasibility of the proposed programs.
Topics: Cost-Benefit Analysis; Diagnostic Services; General Practice; Humans; Physical Examination; Primary Health Care
PubMed: 26895552
DOI: 10.20452/pamw.3303 -
Diagnosis (Berlin, Germany) Aug 2021Clinical laboratory testing provides essential data for making medical diagnoses. Generating accurate and timely test results clearly communicated to the treating... (Review)
Review
OBJECTIVES
Clinical laboratory testing provides essential data for making medical diagnoses. Generating accurate and timely test results clearly communicated to the treating clinician, and ultimately the patient, is a critical component that supports diagnostic excellence. On the other hand, failure to achieve this can lead to diagnostic errors that manifest in missed, delayed and wrong diagnoses.
CONTENT
Innovations that support diagnostic excellence address: 1) test utilization, 2) leveraging clinical and laboratory data, 3) promoting the use of credible information resources, 4) enhancing communication among laboratory professionals, health care providers and the patient, and 5) advancing the use of diagnostic management teams. Integrating evidence-based laboratory and patient-care quality management approaches may provide a strategy to support diagnostic excellence. Professional societies, government agencies, and healthcare systems are actively engaged in efforts to advance diagnostic excellence. Leveraging clinical laboratory capabilities within a healthcare system can measurably improve the diagnostic process and reduce diagnostic errors.
SUMMARY
An expanded quality management approach that builds on existing processes and measures can promote diagnostic excellence and provide a pathway to transition innovative concepts to practice.
OUTLOOK
There are increasing opportunities for clinical laboratory professionals and organizations to be part of a strategy to improve diagnoses.
Topics: Clinical Laboratory Services; Communication; Delivery of Health Care; Diagnostic Errors; Humans; Laboratories
PubMed: 33554526
DOI: 10.1515/dx-2020-0119 -
Ugeskrift For Laeger Mar 2021Risk of genetic diseases with autosomal recessive or X-linked inheritance can be unknown to prospective parents until an affected child is born. New technology has... (Review)
Review
Risk of genetic diseases with autosomal recessive or X-linked inheritance can be unknown to prospective parents until an affected child is born. New technology has enabled carrier screening for hundreds of genetic diseases (expanded carrier screening, ECS). I Denmark, each year estimated 100-180 children are born affected with a serious condition which could have been detected with ECS of the parents. This review describes the considerations and perspectives of a systematic genetic screening programme for prospective parents in the Danish healthcare system.
Topics: Child; Genetic Carrier Screening; Genetic Counseling; Genetic Testing; Humans; Parents; Prospective Studies
PubMed: 33829993
DOI: No ID Found -
CA: a Cancer Journal For Clinicians 2014After a comprehensive review of the evidence, the United States Preventive Services Task Force recently endorsed screening with low-dose computed tomography as an early... (Review)
Review
After a comprehensive review of the evidence, the United States Preventive Services Task Force recently endorsed screening with low-dose computed tomography as an early detection approach that has the potential to significantly reduce deaths due to lung cancer. Prudent implementation of lung cancer screening as a high-quality preventive health service is a complex challenge. The clinical evaluation and management of high-risk cohorts in the absence of symptoms mandates an approach that differs significantly from that of symptom-detected lung cancer. As with other cancer screenings, it is essential to provide to informed at-risk individuals a safe, high-quality, cost-effective, and accessible service. In this review, the components of a successful screening program are discussed as we begin to disseminate lung cancer screening as a national resource to improve outcomes with this lethal cancer. This information about lung cancer screening will assist clinicians with communications about the potential benefits and harms of this service for high-risk individuals considering participation in the screening process.
Topics: Cost-Benefit Analysis; Early Detection of Cancer; Evidence-Based Medicine; Humans; Lung Neoplasms; Mass Screening; Physician's Role; Physicians, Primary Care; Quality of Life; Radiation Dosage; Risk Assessment; Smoking Cessation; Tomography, Spiral Computed; United States
PubMed: 24976072
DOI: 10.3322/caac.21239